Evaluate the Role of a Personalized Smartphone Based Application to Improve Childhood Immunization Coverage

June 25, 2020 updated by: Dr Abdul Momin Kazi, Aga Khan University

To Evaluate the Role of a Personalized Smartphone-based Application to Improve Childhood Immunization Coverage and Timelines Among Children in Pakistan

The vision of the investigators is to build capacity in technology-driven healthcare innovation in LMCIs. The programme will be initiated by a feasibility and proof-of-concept (POC) study to tackle the lack of awareness around immunization, which is a major health issue in developing countries. Mobile apps and social media have been shown to be effective in various programmes worldwide, but there is limited data from LMICs on the use of digital technologies in improving routine immunization (RI) coverage.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Pakistan is one of the countries with the highest rates of child death in the world. It ranks 4th in child mortality, with 60% deaths due to vaccine-preventable diseases (VPDs). The immunization coverage in Pakistan is estimated to be 59%, which is still well below the desired level, leading to continued polio transmission, large measles outbreaks, and thousands of deaths from vaccine-preventable illnesses. In addition, Pakistan is a major polio epidemic country and among 3 countries in the world requiring proof of polio vaccination for international travel. Pakistan demographic and health survey in 2017-2018 suggests 88% percent of children had received BCG vaccine due at birth, 86% and 95% had received the first dose of pentavalent and polio vaccine respectively due at the 6th week. Furthermore, 75% and 86% of children had received the third dose of the pentavalent and polio vaccines, respectively, due at 14th week and measles vaccination was 73%, which is due at 9 months. However, these rates are at 1 year of age and much higher than vaccination coverage rate at scheduled time and among conflict hits and displaced populations. Improved RI coverage is recommended as the priority public health strategy to reduce VPDs and eradicate polio in Pakistan and worldwide.

According to immunization coverage surveys, 1 in 5 children are unimmunized. A major reason for poor childhood vaccine coverage is low immunization uptake, when parents are unable to complete the entire series of vaccines in accordance with the scheduled timelines. Some of the reasons include: (1) the family is not in favor of getting their child immunized, (2) low trust in vaccines provided through Expanded Programme on Immunization (EPI) and government health care providers, and (3) caregivers have forgotten their child's next vaccination due date or child's EPI card is misplaced. These barriers may be modified with additional support through education and behavior change strategies. In addition, with more pressing issues of food and shelter, preventive health often takes the back seat, and parents and caregivers forget or ignore the subsequent doses of vaccines for their children. There is an immense need to encourage parents' care seeking and collaboration with the health care providers to improve initial vaccine uptake and the completion of all doses according to the schedule. New innovative and cost-effective techniques are necessary for practical solutions to improve vaccination uptake and coverage.

Mobile phones offer a new medium to provide education and advocate families or caregivers to enable behavior change so as to improve immunization uptake. Mobile phone use has also increased in countries with low RI coverage and a high risk of VPDs. Good examples are Nigeria and Pakistan, where there were around 170 and 140 million mobile phone subscribers, respectively, in 2014. There are limited data from LMICs set up on the role of SMS-based interventions for improvement of RI coverage, and conventional 1-way reminder SMS text messages were used by most of the studies as the intervention. Overall, very few studies compared reminders, educational, and interactive SMS messages related to childhood vaccination uptake. Although some of the studies have shown some behavior change for improvement in vaccination coverage, more rigorous application of health behavior change model needs to be applied to understand the impact of reminder, educational, and interactive messages on behavior change related to improvement in RI coverage. However, data from developing countries regarding the role of automated calls in improving vaccine coverage are limited.

The vision of the investigators is to build capacity in technology-driven healthcare innovation in LMCIs. The programme will be initiated by a feasibility and proof-of-concept (POC) study to tackle the lack of awareness around immunization, which is a major health issue in developing countries. Mobile apps and social media have been shown to be effective in various programmes worldwide, but there is limited data from LMICs on the use of digital technologies in improving routine immunization (RI) coverage.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
328

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Sindh
      • Karachi, Sindh, Pakistan, 74800
        • Aga Khan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

1 month to 2 months (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • parent or guardian or at least one person in the household has a working android based smart mobile phone
  • ability to use android based smart phone
  • Parent or guardian providing consent.

Exclusion Criteria:

  • If the family will not be visiting AKU for 10- and 14-week RI.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Intervention Arm
The intervention arm in addition to the standard counselling will include receiving text messages, voice messages, pictorial messages and video messages regarding vaccination once a week till the child turns 14 weeks
Behavioral: Android based mobile phone application
An android based mobile application will be developed. The application will have features and capacity for text messages, voice messages, pictorial messages and video messages. The content of the messages will be according to the findings of Paigham e sehat project and the four messages domains would be educational, reminder, religious and adverse effects. In addition, pictorial and video messages would be used as per freely available through EPI programme Pakistan.
NO_INTERVENTION: Control Arm
The control group will receive one-time standard verbal counselling at the time of initial visit for on-time EPI vaccines at 10 and 14 weeks of age as recommended by EPI, government of Pakistan.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
improvement in RI coverage
Time Frame: 12 weeks
to see a 10 percent increase in RI through personalized smart mobile phone-based application at 10 and 14 weeks of age according to the EPI schedule versus standard care
12 weeks
Improvement in timeline
Time Frame: 12 weeks
To see a 10 percent increase in RI within 1 week of the original timeline at 10, and 14 weeks versus standard care
12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Perceptions and barriers related to routine immunization (Interview guide in form of in depth interview will be administered).
Time Frame: 6 weeks
  1. Perceptions regarding risks of infectious diseases preventable by vaccines and vaccine safety and efficacy.
  2. Perceptions and barriers to vaccinating children including difficulties in visiting RI centers.

This will help us in understanding the types of (1) barriers perceived by caregivers, (2) designing the Randomized Controlled Trial and study methodology.
6 weeks
perceptions and barriers of a mobile phone based application to improve immunization coverage (interview guide in form of in depth interview will be administered)
Time Frame: 4 weeks
  1. Perceptions and barriers that may affect the use of mobile phone application in implementing the phone-based intervention to improve immunization coverage
  2. Usability and preferences of mobile phone app to improve routine immunization coverage

This will help in developing personalized mobile phone application and content of the messages according to the barriers of the participants to bring in behavior change in order to improve immunization coverage and timelines

Measurement tool is the 14 weeks vaccination as per EPI schedule.
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Aga Khan University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Surrey
NED University of Engineering and Technology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 27, 2020

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 30, 2020

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 14, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 25, 2020

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 26, 2020

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 26, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 25, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2019-1534-5556

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The database will reside on a central computer at AKU managed by the study staff. Mobile numbers will not be shared except to track patterns of use. Only relevant study staff will have access to study data allowed by the local ethics committee. Participants' information will be given a study code, and no personal identifiers will be shared. Data confidentiality will be maintained at all times. No personal identifiers will be used in any reports or publication of the study. No individual identifier such as names of participants and area of location will be shared. In addition, a confidentiality agreement has been signed with the universities stating that the numbers provided will only be used for the purpose of the trial.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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